FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED VERSACARE FRAME
MDR report key: 1677799
·
Received April 28, 2010
Report
- Report Number
- 1824206-2010-06493
- Event Type
- Malfunction
- Date Received
- April 28, 2010
- Date of Event
- June 20, 2008
- Report Date
- June 20, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TECH FOUND THAT THE E-CLIP WAS MISSING FROM THE SIDERAIL LATCHING BAR. TECH REALIGNED THE SIDERAIL LATCHING BAR AND REPLACED THE E-CLIP TO RESOLVE THE ISSUE. PURSUANT TO OUR RESPONSE TO WARNING LETTER 2008-DT-04, HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT.
Description of Event or Problem · 1
TECH ALLEGED THAT THE HEAD SIDERAIL WOULD NOT LOCK IN THE UP POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSACARE BED VERSACARE FRAME | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM RITTER | P3200D000076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |